Application 216275

Type: ANDA
Sponsor: RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216275-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216275-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216275-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216275-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216275-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216275-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216275-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216275-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216275-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216275-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216275-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216275-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216275-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216275-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216275-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216275-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216275-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216275-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216275-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216275-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216275-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216275-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216275-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216275-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216275-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216275-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216275-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216275-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216275-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	b28e4a68-f396-4c1a-ba38-6a972906b4d0	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Ingenus Pharmaceuticals, LLC	1a237198-ca24-4159-b570-b5a23c8e91b0	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275 ndc (product): 50742-278
Diclofenac sodium	DICLOFENAC SODIUM	BluePoint Laboratories	896e3f7d-88e6-4563-b879-a2757d19fd62	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	1d4d6370-2b45-fa6d-e063-6294a90a4a67	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	6a9c3cea-7b46-427d-99af-90c1f290b190	2023-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-278	Diclofenac sodium	diclofenac sodium	Ingenus Pharmaceuticals, LLC	ANDA	Current